Development and Validation of High Performance Liquid Chromatographic and UV-Derivative Spectrophotometric Methods for the Determination of Sotalol Hydrochloride in Tablets

Abstract

High performance liquid chromatographic (HPLC) and UV derivative spectrophotometric (UVDS) methods were developed and validated for the quantitative determination of sotalol hydrochloride in tablets. The HPLC method was performed on a C18 column with fluorescence detection. The excitation and emission wavelengths were 235 and 310 nm, respectively. The mobile phase was composed of acetonitrile-water containing 0.1% trietylamine (7:93 v/v) and pH adjusted to 4.6 with formic acid. The UVDS method was performed taking a signal at 239.1 nm in the first derivative. The correlation coefficients (r) obtained were 0.9998 and 0.9997 for HPLC and UVDS methods, respectively. The proposed methods are simple and adaptable to routine analysis.

Keywords:

• β-blockers
• high performance liquid chromatography
• pharmaceutical formulations
• sotalol hydrochloride
• UV derivative spectrophotometry

We acknowledge FAPESP (Fundação de Amparo à Pesquisa do Estado de São Paulo) and CNPq (Conselho Nacional de Pesquisa, Brasil) for financial support.

Notes

LOD = limit of detection.

LOQ = limit of quantitation.

∗Arithmetic mean value (n = 10).

∗∗Mean value after statistically treated with ANOVA (n = 30).

Sample A = declared amount 120.0 mg/tablet.

Sample B = declared amount 160.0 mg/tablet.

∗Mean of three determinations.